Department of Drug Administration — Nepal
DDA Nepal · Nepal · asia pacific
Nepal's Department of Drug Administration (Ministry of Health and Population) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under Ayurveda alongside the contemporary biomedical framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Nepal
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.dda.gov.np
Relevant Regulation Codes
- Nepali Drug Act, 2035 (1978) and its amendments
- Nepali Ayurveda Medical Council Act, 2044 (1988)
- Nepali national medical device regulatory framework
Prescriber Requirements
- Nepal Medical Council–registered physician — order required for any biomedical device application
- Ayurveda Medical Council–registered Ayurvedic practitioners may have separate scope, including jalaukavacharana (leech application); specific contemporary authorisation has not been independently verified by ASH
Supply Chain & GMP
DDA registration as applicable; Nepali (Devanagari script) and English-language labelling. Standard cold-chain conditions, with logistical constraints typical of mountainous distribution.
Import/Export Rules
DDA and Department of Livestock Services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Social Health Insurance Board coverage depends on inpatient bundling; outpatient hirudotherapy under Ayurvedic credentialing is variably reimbursed depending on provider type.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Nepal has formal statutory recognition of Ayurveda through the Ayurveda Medical Council, and jalaukavacharana (leech application) is part of Ayurvedic surgical tradition. The interface between Ayurvedic and biomedical regulation for hirudotherapy has not been independently mapped by ASH.
Related Jurisdictions
PMDA — Japan
Japan's medicines and devices regulator — leech therapy classified within the Kampo / traditional-medicine framework under MHLW oversight, with no PMDA-issued device approval to date.
NMPA — China
China's medical-products regulator — leeches (水蛭 / shui zhi) are codified in the Chinese Pharmacopoeia as Traditional Chinese Medicine (TCM) and regulated as a Chinese herbal medicine.
MFDS — South Korea
South Korea's drug-safety regulator (formerly KFDA) — leech therapy practised within the Korean Medicine (한의학 / Hanui) tradition; Hirudo medicinalis listed in the Korean Pharmacopoeia.
CDSCO — India
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.